LSC have a great contract opportunity for a QA Systems Specialist to join a Dublin based Biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life.
If you have previous QA Documentation experience in biopharmaceutical manufacturing and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
The QA Systems Specialist will join the Document Control Team and, along with other team members, will act as a key point of contact and provide cross-departmental support for a variety of document management systems and processes.
Key Duties and Responsibilities:
- Preparation and issuance of controlled documentation to support manufacturing and testing activities
- Development and maintenance of the Documentation Management System
- Provision of training and user support for the Document Management System
- Management of the Document Archive and Record Retention Systems
- Maintenance of other document systems and processes e.g. SharePoint, Periodic Review tracking.
- Delivery of GMP/GDP training
- Participation in the internal and external audit program
- Support completion of investigation/CAPA activities as applicable to role
- Authoring, review and approval of QA-related procedures
ARE YOUR SKILLS A MATCH?
- The successful candidate will hold a BSc in life sciences/pharmacy or similar
- A minimum 1-2 years' Quality experience in a pharmaceutical environment is adventitious
- Working knowledge of cGMP requirements for manufacturing and/or systems and compliance.
- The candidate must be able to work across a team matrix in order to meet accelerated timelines
- The candidate must be able to reprioritise tasks as required to meet changing demands.
Please apply directly via this advert or contact Kathy Gillen on 021 4718212 to discuss this opportunity in more detail.
All applicants must have a valid work permit for at least 12 months . LSC cannot offer work permit or visa sponsorship.
